Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Objective: Performs calibration testing on assigned laboratory and plant equipment to assure proper working condition is maintained.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
Perform routine calibration of various devices such as temperature, pressure, flow, and humidity instrumentation. as assigned by calibration supervisor, or manager. Maintain all documentation in an organized and controlled manner in compliance with cGMP and FDA. Produce and maintain the proper paperwork (data sheets, certificates, stickers, etc.) for each job. Review certificates for correctness. Document the performance of calibration activities according to priorities and policy. Manage workload to achieve production schedules and ensure completion within the timeframe. Reporting OOS results when results fall out with the expected ranges and performing instrument adjustments where applicable Ensure that assets and supplies are maintained and stored properly. Data entry and database used by any internal SOPs and external regulatory requirements. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules. Performs other duties as assigned by Manager/Supervisor. Attendance to work is an essential function of this position This position may require overtime and/or weekend work.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Required:
Associate's Degree in a related field and/or 1-3 years related experience and/or training.College Level Mathematical SkillsIntermediate Computer Skills: Ability to perform more complex computer tasks and knowledge of various computer programs. Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.Preferred
Ability to follow instructions and respond to management direction.Ability to identify and resolve problems promptly.Ability to display excellent time management skills.Ability to demonstrate attention to detail.#LI-SW1
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.